Tylenol is a brand known around the world. The pain reliever and fever reducer is commonly used to treat a wide swath of medical issues, from headaches and backaches to colds and fevers. Not only do an estimated 52 million Americans use a Tylenol product every week but Tylenol is given to patients of all ages.
Despite the widespread use of Tylenol, the drug carries side effects that could be deadly for countless users. These side effects have resulted in some doctors calling Tylenol by far the most dangerous drug ever made.
The dangers associated with Tylenol have resulted in thousands of deaths over the decades and hundreds of lawsuits.
Background of Tylenol
Tylenol is the trade name for a brand of drugs containing acetaminophen, also known as paracetamol. All three names are derived from the name of the chemical compound N-acetyl-para-aminophenol.
It is an over-the-counter medication sold in the United States and across the globe as a pain reliever and fever reducer. Tylenol is most commonly used to reduce pain and fever as well as treat the symptoms of a cough, headache, the flu, cold, and allergies.
The drug itself has a long history that dates back to 1886 when a pharmacist accidentally mixed two chemicals to create an early iteration of the drug. Three years later it was made into acetaminophen. Shortly after, acetaminophen was released in a number of drugs in the United States with different names like Telephone Headache Tablets and U-Re-Ka Headache Powders.
The name Tylenol did not come about until the 1950s when the brothers at McNeil Laboratories heard about a European drug to treat children. By 1955, McNeil Laboratories had started selling Children’s Tylenol Elixir inside a small plastic fire truck as a prescription painkiller.
Johnson & Johnson bought McNeil Laboratories in 1959. Within a year of the deal, Tylenol was sold as an over-the-counter drug without a prescription. In 1974, it was sold to adults in the Tylenol extra strength capsule.
Since then, acetaminophen has been used in hundreds of drugs on the market, from over-the-counter liquids to prescription pills. The widespread use helped propel the drug to become one of the most widely used medicines in the country. In 2008 alone, there were more than 27 billion doses sold.
How Does Tylenol Work?
Despite being used by countless people around the world, scientists still aren’t entirely sure how Tylenol works. Researchers have made several educated guesses on the effect Tylenol has on the body.
One theory according to an issue of Chemical and Engineering News suggests that Tylenol blocks something called cyclooxygenase (COX) enzymes. These enzymes help form chemicals called prostaglandins, which send pain signals to the brain. This is similar to how other pain-relieving drugs like ibuprofen function.
Another thought is that Tylenol affects both the enzymes and the endocannabinoid system, another way pain signals are sent to the brain.
A third theory is that Tylenol targets the serotonin neurotransmitter in the central nervous system. Serotonin may play a role in some pain disorders like migraines.
Scientists believe that the three theories may not be mutually exclusive and could work in concert with one another to help relieve pain. Researchers are continuing to explore what makes Tylenol work to create better pain relievers.
Types of Tylenol
Acetaminophen is found in hundreds of different products on the market from a number of pharmaceutical companies. Johnson & Johnson subsidiary McNeil Laboratories sells more than two dozen iterations of Tylenol products containing acetaminophen.
Here are just a few of the Tylenol products on the market:
- Regular Strength Tylenol
- Tylenol Regular Strength Liquid Gels
- Tylenol Rapid Release Gels
- Tylenol Extra Strength Caplets
- Tylenol 8 Hr Muscle Aches & Pain Caplets
- Tylenol 8 Hr Arthritis Pain
- Tylenol Cold + Flu Severe Day/Night
- Children’s Tylenol Oral Suspension
- Children’s Tylenol Cold + Cough + Sore Throat Oral Suspension
- Children’s Tylenol Cold + Cough + Runny Nose Oral Suspension
- Children’s Tylenol Chewables
- Tylenol PM
- Infant’s Tylenol Oral Suspension
- Tylenol Sinus + Headache Daytime Caplets
- Tylenol Sinus Severe Daytime Caplets
- Tylenol Cold Max Daytime Citrus Burst Liquid
- Tylenol Cold + Sore Throat Cool Burst Liquid
- Tylenol Cold + Mucus Severe Cool Burst Liquid
- Tylenol Cold Max Nighttime Cool Burst Liquid
Tylenol Side Effects
Most Tylenol labeling does not come with a list of common side effects experienced by users of the drug because it will typically not have any. However, some pharmacists have collected some of the side effects observed in users.
- Stomach pain
- Loss of appetite
- Dark urine
Overdosing on Tylenol on the Rise
Although overdosing is more commonly associated with stronger drugs and prescription medications, overdosing on Tylenol is a real danger. There is a fine line between a proper dosage and too much. This makes it easy to overdose on the drug.
The number of overdoses on Tylenol is alarming.
According to an investigation into the dangers of Tylenol, ProPublica reported that data compiled by the U.S. Food and Drug Administration (FDA) “has linked as many as 980 deaths in a year to drugs containing acetaminophen.” The number of deaths has been increasing faster than other pain-relieving drugs like aspirin and ibuprofen.
The U.S. Centers for Disease Control and Prevention reports that more than 300 people die every year from acetaminophen poisoning. The American Association of Poison Control Centers also says that the number of deaths attributed to acetaminophen accounts for more than all other over-the-counter pain relievers combined since 2006.
The varying strengths and different dosages for each product make it difficult to keep track of when to take medications. For example, the recommended dose for Regular Strength Tylenol is two tablets every 4 to 6 hours while the recommended dose for Tylenol 8 Hr Arthritis Pain is two caplets every eight hours. The U.S. Food and Drug Administration says that even just a small amount more than the recommended daily dose can lead to serious complications.
Tylenol Liver Damage Connection
The most serious side effect connected to the use of too much Tylenol is liver damage.
When Tylenol is taken, a toxic byproduct called NAPQI is created during the metabolism of acetaminophen. With normal doses, the liver is often able to detoxify the byproduct without issue. During an overdose of Tylenol, NAPQI may not be properly detoxified. This could cause severe liver damage, including liver failure and death.
Studies and post-marketing analysis of the drug have pointed to a strong connection between acute liver injury and too much use of Tylenol. Those who consume alcohol or take certain medications are also at an elevated risk of developing liver damage.
Liver damage has also been found in fetuses whose mothers took Tylenol.
Symptoms & Treatment of Tylenol Overdose
Those who overdose on Tylenol usually do not show any symptoms until 24 to 48 hours after ingestion. The minimum toxic dosage for acetaminophen is between 7.5 and 10 g for adults and 150 mg for children.
Medscape reports that Tylenol overdose is broken down into four phases.
- In the first phase within 24 hours, there may be some vomiting or no symptoms at all.
- Phase 2 is from 18 to 72 hours after ingestion. Patients will experience pain in the upper right area of the abdomen and experience vomiting and nausea. There may be decreased urinary output.
- Nausea, vomiting, and abdominal pain continue in Phase 3, which is roughly 72 to 96 hours later. Liver damage or failure may manifest itself as jaundice, hypoglycemia, coagulopathy, or hepatic encephalopathy. Acute renal failure may develop, and death from organ failure may occur.
- Phase 4 is four days to three weeks after ingestion. Those who survive will experience complete resolution of symptoms.
Due to the severe nature of a Tylenol overdose, treatment is important as soon as possible following ingestion. When treated quickly, liver damage may be minor. However, as it advances, damage can be irreversible and deadly.
Emergency personnel will sometimes treat overdoses by emptying the stomach, administering the antidote for acetaminophen overdose, or giving activated charcoal by mouth.
FDA Takes Action Against Tylenol for Liver Damage
From 1998 to 2003, drugs containing Tylenol were the leading cause of liver failure in the United States. Nearly half were from an accidental overdose.
As a result, the FDA started working to address the problem. In 1998, the FDA required all drugs containing acetaminophen to include a warning about alcohol on their labels. Alcohol and acetaminophen can increase the risk of liver damage.
In 2009, the FDA issued a final rule changing labels to reflect the dangers of overdosing and the risk of liver injury. Two years later, the FDA asked manufacturers to limit the strength of acetaminophen in prescription drugs and added a black box warning — the FDA’s strongest warning — about severe liver injury.
Throughout this time, the FDA warned about other dangers and complications with Tylenol-containing products, including the risk of allergic reactions and dangers to pregnant women.
Users File Tylenol Lawsuits as Early as 1994
The problem of overdosing on Tylenol has led to lawsuits against Johnson & Johnson and McNeil Consumer Products Company.
In one of the first lawsuits, plaintiff Antonio Benedi sued McNeil after he lost his liver while taking Tylenol with wine. A jury awarded him $7.8 million in compensatory damages and found that McNeil failed to warn of the dangers of mixing alcohol and Tylenol. The company denied the connection and blamed a pre-existing viral infection.
Since then, hundreds of people have filed lawsuits against Johnson & Johnson and McNeil related to liver damage.
Allegations in Tylenol Liver Damage Lawsuits
Those who suffered liver damage after taking Tylenol claim that the companies negligently designed and manufactured Tylenol and failed to warn the public of unexpected side effects.
They also claim the companies misrepresented the safety and efficacy of the drug to make more money from consumers.
In one case, a woman named Charlotte Lee Thompson sued Johnson & Johnson and McNeil after experiencing liver failure while taking Tylenol for several days. She claimed to have taken the correct dosage before she had to go to the emergency room to treat severe liver damage in 2008.
She sued the companies for negligent and wrongful conduct in the design development, manufacture, testing, promoting, labeling, and distribution of Tylenol.
Her case was similar to hundreds of others filed against the companies.
Settlement Reached in Over 200 Cases
Cases against the two companies were eventually moved under multidistrict litigation in federal court after a judge found them to all contain similar factual questions.
The first bellwether case went to trial in October 2015. A jury in New Jersey found the plaintiff did not adequately prove that she had taken Tylenol before her hospitalization for liver damage occurred. However, they did not dismiss her claims that Tylenol could have caused her injuries. Other plaintiffs settled out of court before going to additional bellwether trials.
In February 2017, McNeil agreed to settle more than 200 Tylenol liver damage lawsuits for an undisclosed amount. The terms of the proposed settlement have not been revealed, The U.S. Judicial Panel on Multidistrict Litigation reports that there are still 22 pending actions in court as of March 2018.
Some attorneys expect more cases related to Tylenol and liver damage to be filed in the future. Those who think they have a case are encouraged to contact a lawyer to find out more.